In my opinion it is not a major non-conformity. It seems that section 7.3 is implemented in your QMS, so the issue of, in some cases, not...
You could consider SharePoint, that works for a lot of small companies.
Happy birthday from me too. :)
I am not in any way affiliated but take a look at ETQ, they have a SaaS solution that is affordable and very, very nice.
Hi, and welcome to the forum :) I have a good feeling that this will prove a worthy successor to the Cove, as long as we spread the word and get...
Quality activities are any activities covered by 21 CFR (you might call them predicate rules) including the current FDA interpretation of the...
All software used for quality activities in an FDA regulated company needs to be validated for its intended purpose. The point about automation is...
I beg to differ :) Using a well designed and compliant database can improve the handling time quite significantly - I have seen reduction in case...
In ISO 13485 and - I believe - all other regulatory systems the word Shall implies a mandatory activity. What verbiage you use in your own QMS is...
Separate names with a comma.